Colazal

DRUG DESCRIPTION

Each COLAZAL capsule contains 750 mg of balsalazide disodium, a prodrug that is enzymatically cleaved in the colon to produce mesalamine (5-aminosalicylic acid or 5-ASA), an anti-inflammatory drug. Each capsule of COLAZAL (balsalazide) (750 mg) is equivalent to 267 mg of mesalamine. Balsalazide disodium has the chemical name (E)-5-[[-4-[[(2- carboxyethyl) amino]carbonyl] phenyl]azo]-2-hydroxybenzoic acid, disodium salt, dihydrate. Its structural formula is:

COLAZAL (Balsalazide disodium) structural formula illustration

Molecular Weight: 437.32

Molecular Formula: C17H13N3O6Na22H2O

Balsalazide disodium is a stable, odorless orange to yellow microcrystalline powder. It is freely soluble in water and isotonic saline, sparingly soluble in methanol and ethanol, and practically insoluble in all other organic solvents.

Inactive Ingredients: Each hard gelatin capsule contains colloidal silicon dioxide and magnesium stearate. The sodium content of each capsule is approximately 86 mg.

What are the possible side effects of balsalazide (Colazal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using balsalazide and call your doctor at once if you have any of these serious side effects:

  • worsening colitis symptoms, such as fever, stomach pain, cramps, or bloody diarrhea;
  • bleeding from your rectum; or
  • pale skin, easy bruising, weakness.

Less serious side effects may include:

  • headache, sleep problems...

Read All Potential Side Effects and See Pictures of Colazal

What are the precautions when taking balsalazide (Colazal)?

Before taking balsalazide, tell your doctor or pharmacist if you are allergic to it; or to aspirin, NSAIDs (e.g., ibuprofen, celecoxib), or salicylates (e.g., salsalate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal blockage (e.g., pyloric stenosis), liver disease, kidney disease.

This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (e.g., salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine...

Read All Potential Precautions of Colazal


Colazal Consumer (continued)

SIDE EFFECTS: Headache, nausea, vomiting, joint pain, abdominal pain, trouble sleeping, or loss of appetite may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, balsalazide can worsen ulcerative colitis. Tell your doctor immediately if your symptoms worsen after starting this medication (e.g., increased abdominal pain, rectal bleeding).

Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes, change in the amount of urine, yellowing eyes/skin, dark urine, unusual/extreme tiredness, severe stomach/abdominal pain, persistent nausea/vomiting, signs of infection (e.g., fever, persistent sore throat, burning/painful urination), easy bruising/bleeding, fast/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking balsalazide, tell your doctor or pharmacist if you are allergic to it; or to aspirin, NSAIDs (e.g., ibuprofen, celecoxib), or salicylates (e.g., salsalate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal blockage (e.g., pyloric stenosis), liver disease, kidney disease.

This medication is similar to aspirin. Children and teenagers should not take aspirin or aspirin-related medications (e.g., salicylates) if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine (e.g., varicella vaccine), without first consulting a doctor about Reye's syndrome, a rare but serious illness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Colazal Patient Information Including Side Effects

Brand Names: Colazal

Generic Name: balsalazide (Pronunciation: bal SAL a zide)

  • What is balsalazide (Colazal)?
  • What are the possible side effects of balsalazide (Colazal)?
  • What is the most important information I should know about balsalazide (Colazal)?
  • What should I discuss with my healthcare provider before taking balsalazide (Colazal)?
  • How should I take balsalazide (Colazal)?
  • What happens if I miss a dose (Colazal)?
  • What happens if I overdose (Colazal)?
  • What should I avoid while taking balsalazide (Colazal)?
  • What other drug's will affect balsalazide (Colazal)?
  • Where can I get more information?

What is balsalazide (Colazal)?

Balsalazide reduces the actions of chemicals in the body that cause inflammation in the colon (bowel).

Balsalazide is used to treat active ulcerative colitis.

Balsalazide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of balsalazide (Colazal)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using balsalazide and call your doctor at once if you have any of these serious side effects:

  • worsening colitis symptoms, such as fever, stomach pain, cramps, or bloody diarrhea;
  • bleeding from your rectum; or
  • pale skin, easy bruising, weakness.

Less serious side effects may include:

  • headache, sleep problems (insomnia);
  • nausea, vomiting, stomach pain, diarrhea;
  • runny nose, cold symptoms; or
  • joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about balsalazide (Colazal)?

Do not use this medication if you are allergic to balsalazide or to salicylates (such as aspirin, Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others).

Before taking balsalazide, tell your doctor if you have a stomach disorder called pyloric stenosis, kidney disease, or an infection that you are treating with antibiotics.

Tell your doctor if your symptoms get worse after you start taking balsalazide.

Balsalazide may interact with antibiotics. Tell your doctor if you need to take an antibiotic during treatment with balsalazide.

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